CN101467988B - Medicament composition containing paracetamol and pseudoephedrine hydrochloride and preparation method thereof - Google Patents
Medicament composition containing paracetamol and pseudoephedrine hydrochloride and preparation method thereof Download PDFInfo
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- CN101467988B CN101467988B CN200710304298.5A CN200710304298A CN101467988B CN 101467988 B CN101467988 B CN 101467988B CN 200710304298 A CN200710304298 A CN 200710304298A CN 101467988 B CN101467988 B CN 101467988B
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- acetaminophen
- pseudoephedrine hydrochloride
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- compressibility
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Abstract
The invention discloses a stable pharmaceutical composition and method for preparing same. The composition contains acetaminophen, pseudoephedrine hydrochloride and pharmaceutically acceptable accessories capable of improving disadvantages such as bad fluidity and compressibility, and electrostatic absorption during the production of acetaminophen which is suitable for industrialized production.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, particularly a kind of Pharmaceutical composition that contains Paracetamol Pseudoephedrine and preparation method thereof.
Background technology
Acetaminophen and pseudoephedrine hydrochloride are the Common drugs for the treatment of flu, and due to evident in efficacy, the commercially available compound preparation that is used for the treatment of common cold or influenza symptom contains this two kinds of medicines mostly at present.Acetaminophen is all raw materials of extreme difference of a kind of mobility, compressibility, and in production operation process, can make to produce a large amount of static in medicine or medicine vessel, thereby makes troubles and the loss of material is increased to operating process.Conventionally can add multiple or a large amount of adjuvants to improve acetaminophen mobility, compressibility, and use the special installations such as ion bar to eliminate Electrostatic Absorption, operate loaded down with trivial details and waste material.How to improve acetaminophen poor fluidity, poor compressibility, generation Electrostatic Absorption etc. and there is no solution effectively.
A kind of preparation method of paracetamol pseudoephedrine hydrochloride and cholrphenamine maleate oral disintegration tablet is disclosed in CN1803136A: acetaminophen is mixed homogeneously to granulation with partially filled agent, all the other two kinds of principal agents are made solution with spray packaging material material, spray is wrapped in obtained acetaminophen particles, acetaminophen particles after spray being wrapped with coating material is again carried out taste masking coating, obtain taste masked particle, then by gained taste masked particle and other auxiliary materials and mixing, tabletting, obtain, operating procedure is comparatively loaded down with trivial details.
In CN1511514A, disclose a kind of acetaminophen particles and preparation method with slow releasing function, in operation, needed fluidized bed coating equipment.
In CN1311672A, disclose a kind of injection pharmaceutical composition that contains acetaminophen, but there is the shortcomings such as administering mode is special, use is inconvenient in injection.
The present invention is devoted to develop a kind of oral administration solid form of administration, improves the technical difficulty that acetaminophen poor fluidity in production process, poor compressibility, generation Electrostatic Absorption etc. cause.
Summary of the invention
The object of this invention is to provide a kind of Pharmaceutical composition that contains anti-common cold or influenza class medicine acetaminophen and pseudoephedrine hydrochloride and preparation method thereof, thereby can solve technological difficulties and the problem that acetaminophen poor fluidity in production process, poor compressibility, generation Electrostatic Absorption etc. cause.
The invention provides a kind of compositions for the treatment of and alleviating common cold or the pseudo-fiber crops of grippal compound paracetamol that contains, formed by active component and adjuvant, contain acetaminophen 30%～65%, pseudoephedrine hydrochloride 2%～8%, filler 10%～65%, disintegrating agent 3%～15%.
Paracetamol Pseudoephedrine compositions of the present invention can be prepared by following method: take acetaminophen and the spray-dired lactose monohydrate of ormal weight, jointly grind or micronization, after mix homogeneously, then add all the other adjuvants.
Compositions provided by the present invention is a kind of compositions that contains spray-dired lactose monohydrate, by common to itself and acetaminophen grind or micronization after, common granulation, there is the acetaminophen of improvement mobility and compressibility, minimizing Electrostatic Absorption, thereby simplify technique, cost-saving.
Compositions provided by the present invention, is a kind of oral administration solid form of administration, has taking convenience, is easy to carry about with one, the advantage of storage-stable.Preparation method of composition provided by the present invention, easy and simple to handle, economical and practical.
Compositions provided by the present invention, accounts for 30%～65% of composition weight as applicable acetaminophen of the present invention, and pseudoephedrine hydrochloride accounts for 2%～8% of composition weight.
Compositions provided by the present invention, comprises filler, binding agent, disintegrating agent, lubricant, correctives as applicable adjuvant of the present invention.
Compositions provided by the present invention, account for 10%～65% of composition weight as applicable filler of the present invention, can be selected from one or more the mixture in lactose, sorbitol, mannitol, sucrose, microcrystalline Cellulose, calcium hydrogen phosphate, starch pregelatinized Starch.
Compositions provided by the present invention, is spray-dired lactose monohydrate as applicable filler of the present invention, and weight counts 25%～100% with acetaminophen.
The mixture of optional one or more in polyvinylpyrrolidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, methylcellulose, sodium alginate of binding agent in the present invention.
In the present invention, disintegrating agent can be selected from one or more the mixture in carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose.
Preparation method of composition provided by the present invention, is by after acetaminophen and the common grinding of spray-dired lactose monohydrate or micronization as applicable operation of the present invention, then mixes with rest materials.
Detailed description of the invention
By following examples, composition and method of making the same of the present invention is done further and illustrated, but be not limited in following instance.
Embodiment 1:
| Component | Percentage by weight (%) |
| Pre-paying of the spray-dired lactose monohydrate of acetaminophen pseudoephedrine hydrochloride starch L-HPC L-HPC polyvinylpyrrolidone magnesium stearate Total | 35 3.0 32 23 2.0 2.0 2.0 1.0 100 |
Preparation method:
Taking the acetaminophen of recipe quantity and spray-dired lactose monohydrate puts in Universalpulverizer and pulverizes, pseudoephedrine hydrochloride is with after mortar porphyrize, mix homogeneously by the equivalent method of progressively increasing with pre-paying starch, L-HPC, taking polyvinylpyrrolidone is made into aqueous solution and granulates as binding agent, additional residue L-HPC, adds magnesium stearate, mixes, tabletting, to obtain final product.
Comparative example 1:
| Component | Percentage by weight (%) |
| Pre-paying of acetaminophen pseudoephedrine hydrochloride microcrystalline Cellulose starch L-HPC L-HPC polyvinylpyrrolidone magnesium stearate Total | 35 3.0 32 23 2.0 2.0 2.0 1.0 100 |
Preparation method:
The acetaminophen that takes recipe quantity is put in Universalpulverizer and is pulverized, pseudoephedrine hydrochloride is with after mortar porphyrize, mix homogeneously by the equivalent method of progressively increasing with pre-paying starch, microcrystalline Cellulose, L-HPC, taking polyvinylpyrrolidone is made into aqueous solution and granulates as binding agent, additional residue L-HPC, adds magnesium stearate, mixes, tabletting, to obtain final product.
Embodiment 2:
| Component | Percentage by weight (%) |
| The spray-dired lactose monohydrate polyvinylpolypyrrolidone of acetaminophen pseudoephedrine hydrochloride hydroxypropyl methylcellulose micropowder silica gel Total | 65 8.0 20 4.0 2.0 1.0 100 |
Preparation method:
The acetaminophen and the spray-dired lactose monohydrate that take recipe quantity are jointly put in Universalpulverizer and are pulverized, pseudoephedrine hydrochloride is with after mortar porphyrize, mix homogeneously with polyvinylpolypyrrolidone, taking hydroxypropyl methylcellulose is made into aqueous solution and granulates as binding agent, additional micropowder silica gel mix homogeneously, incapsulate, to obtain final product.
Comparative example 2:
| Component | Percentage by weight (%) |
| Acetaminophen pseudoephedrine hydrochloride lactose polyvinylpolypyrrolidone hydroxypropyl methylcellulose micropowder silica gel Total | 65 8.0 20 4.0 2.0 1.0 100 |
Preparation method:
The acetaminophen and the lactose that take recipe quantity are jointly put in Universalpulverizer and are pulverized, and pseudoephedrine hydrochloride, with after mortar porphyrize, is mixed homogeneously with polyvinylpolypyrrolidone, taking hydroxypropyl methylcellulose is made into aqueous solution and granulates as binding agent, additional micropowder silica gel mix homogeneously, incapsulates, and to obtain final product.
Embodiment 3:
| Component | Percentage by weight (%) |
| The spray-dired lactose monohydrate carboxymethyl starch sodium of acetaminophen pseudoephedrine hydrochloride microcrystalline Cellulose starch magnesium stearate Total | 54 5.0 15 20 3.0 2.0 1.0 100 |
Preparation method:
Taking the acetaminophen of recipe quantity and spray-dired lactose monohydrate puts in Universalpulverizer and pulverizes, pseudoephedrine hydrochloride is with after mortar porphyrize, mix homogeneously by the equivalent method of progressively increasing with microcrystalline Cellulose, carboxymethyl starch sodium, take starch and be made into aqueous solution as binding agent granulation, add magnesium stearate, mix, tabletting, to obtain final product.
Comparative example 3:
| Component | Percentage by weight (%) |
| Acetaminophen pseudoephedrine hydrochloride microcrystalline Cellulose sorbitol carboxymethyl starch sodium starch magnesium stearate Total | 54 5.0 15 20 3.0 2.0 1.0 100 |
Preparation method:
The acetaminophen and sorbitol, the microcrystalline Cellulose that take recipe quantity are jointly put in Universalpulverizer and are pulverized, pseudoephedrine hydrochloride is with after mortar porphyrize, mix homogeneously by the equivalent method of progressively increasing with carboxymethyl starch sodium, take starch and be made into aqueous solution as binding agent granulation, add magnesium stearate, mix, tabletting, to obtain final product.
Embodiment and comparative example's comparison sheet
| Angle of repose (°) | Compressibility | Granule yield (%) | |
| Embodiment 1 comparative example 1 embodiment 2 comparative example 2 embodiment 3 comparative examples 3 | 30.13 40.59 32.41 42.06 31.55 40.64 | The good poor compressibility of the good poor compressibility compressibility of the good poor compressibility compressibility of compressibility | 95.88 91.24 96.31 90.98 95.51 90.71 |
Result shows: in the operating process of three embodiment, the mobility of granule, compressibility be all significantly better than three comparative examples, and due to the subduing of Electrostatic Absorption, the loss of material reduces, and granule yield obviously increases.
Claims (2)
1. contain a Pharmaceutical composition for Paracetamol Pseudoephedrine, in weight ratio, it is characterized in that:
(1) acetaminophen 65.0%, pseudoephedrine hydrochloride 8.0, a spray-dired Lactose hydrate 20.0%, polyvinylpolypyrrolidone 4.0%, hydroxypropyl emthylcellulose 2.0%, micropowder silica gel 1.0%;
(2) wherein acetaminophen is pulverized and mixed in advance with the dried lactose of spraying, obtains its pharmaceutical composition.
2. Pharmaceutical composition according to claim 1, is characterized in that spray-dired lactose monohydrate and acetyl aminophenol are pulverized and mixed in advance, and in weight ratio, the content of spray-dired lactose monohydrate is 20.0%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200710304298.5A CN101467988B (en) | 2007-12-27 | 2007-12-27 | Medicament composition containing paracetamol and pseudoephedrine hydrochloride and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200710304298.5A CN101467988B (en) | 2007-12-27 | 2007-12-27 | Medicament composition containing paracetamol and pseudoephedrine hydrochloride and preparation method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN101467988A CN101467988A (en) | 2009-07-01 |
| CN101467988B true CN101467988B (en) | 2014-07-09 |
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| CN200710304298.5A Expired - Fee Related CN101467988B (en) | 2007-12-27 | 2007-12-27 | Medicament composition containing paracetamol and pseudoephedrine hydrochloride and preparation method thereof |
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| CN112198274B (en) * | 2020-11-02 | 2022-04-05 | 北京市理化分析测试中心 | Method for detecting pseudoephedrine hydrochloride in paracetamol and pseudoephedrine hydrochloride tablet |
Citations (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1122103A (en) * | 1993-04-30 | 1996-05-08 | 普罗克特和甘保尔公司 | Coated pharmaceutical compositions |
| CN1397556A (en) * | 2002-08-27 | 2003-02-19 | 何广卫 | Alkali-metal or alkali-earth metal salt of polyprotic acid delotadine and its medical composition |
| CN1426297A (en) * | 2000-04-27 | 2003-06-25 | 诺沃恩Ip控股公司 | Directly compressed solid dosage particles |
| CN1476898A (en) * | 2002-08-23 | 2004-02-25 | 涛 吴 | Compound skeleton tablet capable of prolonging release after oral administrationi for curing common cold |
| CN1626080A (en) * | 2003-12-11 | 2005-06-15 | 江苏晨牌药业有限公司 | Paracetamol Pseudoephedrine desintegration piece and preparation method |
| CN1634118A (en) * | 2004-11-05 | 2005-07-06 | 凌沛学 | Antivirus formulation containing polysaccharide polyanion zinc salt and its preparing process |
| CN1771915A (en) * | 2005-10-17 | 2006-05-17 | 重庆医药工业研究院有限责任公司 | Oral disintegrated Anfenmame tablet for treating children's cold and its prepn |
| CN1806802A (en) * | 2006-02-23 | 2006-07-26 | 北京阜康仁生物制药科技有限公司 | Pharmaceutical composition with acetaminopher, loratadine and pseudoephedrine sulfate as active ingredients, preparation method and uses thereof |
| CN1872039A (en) * | 2006-04-17 | 2006-12-06 | 毛晓敏 | Rotula of acetaminopher suitable for children to take, and prepartion method |
| CN1994278A (en) * | 2006-11-21 | 2007-07-11 | 北京润德康医药技术有限公司 | Sustained-release preparation using acetaminopher, desloratadine and pseudo ephedrine sulfat as active ingredients and preparation process thereof |
| CN101002755A (en) * | 2007-01-10 | 2007-07-25 | 复旦大学 | Compounding and pulsation-releasing preparation, and its preparing method |
-
2007
- 2007-12-27 CN CN200710304298.5A patent/CN101467988B/en not_active Expired - Fee Related
Patent Citations (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1122103A (en) * | 1993-04-30 | 1996-05-08 | 普罗克特和甘保尔公司 | Coated pharmaceutical compositions |
| CN1426297A (en) * | 2000-04-27 | 2003-06-25 | 诺沃恩Ip控股公司 | Directly compressed solid dosage particles |
| CN1476898A (en) * | 2002-08-23 | 2004-02-25 | 涛 吴 | Compound skeleton tablet capable of prolonging release after oral administrationi for curing common cold |
| CN1397556A (en) * | 2002-08-27 | 2003-02-19 | 何广卫 | Alkali-metal or alkali-earth metal salt of polyprotic acid delotadine and its medical composition |
| CN1626080A (en) * | 2003-12-11 | 2005-06-15 | 江苏晨牌药业有限公司 | Paracetamol Pseudoephedrine desintegration piece and preparation method |
| CN1634118A (en) * | 2004-11-05 | 2005-07-06 | 凌沛学 | Antivirus formulation containing polysaccharide polyanion zinc salt and its preparing process |
| CN1771915A (en) * | 2005-10-17 | 2006-05-17 | 重庆医药工业研究院有限责任公司 | Oral disintegrated Anfenmame tablet for treating children's cold and its prepn |
| CN1806802A (en) * | 2006-02-23 | 2006-07-26 | 北京阜康仁生物制药科技有限公司 | Pharmaceutical composition with acetaminopher, loratadine and pseudoephedrine sulfate as active ingredients, preparation method and uses thereof |
| CN1872039A (en) * | 2006-04-17 | 2006-12-06 | 毛晓敏 | Rotula of acetaminopher suitable for children to take, and prepartion method |
| CN1994278A (en) * | 2006-11-21 | 2007-07-11 | 北京润德康医药技术有限公司 | Sustained-release preparation using acetaminopher, desloratadine and pseudo ephedrine sulfat as active ingredients and preparation process thereof |
| CN101002755A (en) * | 2007-01-10 | 2007-07-25 | 复旦大学 | Compounding and pulsation-releasing preparation, and its preparing method |
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